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CNN Lou Dobbs Tonight - Transcript

PILGRIM: Well, my next guest is taking on drug companies and the FDA for what he calls a conspiracy of silence. Congressman Ed Markey of Massachusetts says many drug companies are abusing the FDA's accelerated approval program for drugs that treat life-threatening diseases. And he says drug makers are failing to conduct vital follow-up study on the drugs after they hit the market.

And Congressman Markey has just released an extensive report detailing the charges and he joins me now.

And thanks for being here.

REP. ED MARKEY (D), MASSACHUSETTS: Thank you for having me in.

PILGRIM: Let's clear this up. These are drugs that were basically put through quickly so that they could save lives. And the FDA requires additional testing to make sure they're OK. They're not doing the additional testing, that's what you found in many cases.

MARKEY: That's right. So, in other words, because the drug is so important, because it can save lives, they go right around the regulatory process. They're approved quickly, but with safety and effectiveness tests which have yet to be completed.

The drug company promises that they will complete the tests. But what I found in looking at FDA records is that drug companies go three, four, five, six, seven years, sometimes, before they actually finish all of these safety and effectiveness tests. Meanwhile, patients and doctors are using these drugs without knowing whether or not, in fact, they have passed these exams.

PILGRIM: There are some startling statistics that you've turned up: 42 of the -- 42 of the drugs that were required by the FDA to have follow-up testing, 42 of 91 did not since is the 1992. That's a good percentage, and yet many people, I'm sure, are quite happy to get the drugs if they are in a life-threatening illness.

I was particularly struck by the-an example of a lung cancer drug that, of course, you would want immediately if you could get it, and yet later testing proved that it had absolutely no effect whatsoever, potentially harmless. Why would that be a problem?

MARKEY: It would be a problem because people, in many instances, because they know they have these illnesses, will pay anything and they should know as soon as possible that the drug is not effective, because then they, with their physician, might be able to construct some other strategy. But the patient has a right to know that the drug is not effective, and as soon as possible. Here, what we're finding is that these safety and effectiveness tests are not completed for years after approval has been given.

PILGRIM: Yes, in this case, it was $1,800 a month for this particular drug, and they could be taking something else. That's the other point, isn't it?

MARKEY: They could be taking something else, and moreover, there is no requirement by the FDA that this conditional approval be put on the label. In other words, the doctor and the patient aren't even told on the label that it's a conditional approval. The doctor or the patient would have to go to the FDA website, the drug company website, to find that out but they wouldn't see it, obviously, when they were purchasing the drug or consuming it on a daily basis.

PILGRIM: Now, the FDA, we did speak to them. They say they closely monitor the process and in some cases the additional trials can take years to complete, so that's what they are saying about this when we spoke to them today. But, you're saying there is a way to fix this and you're suggesting alternate labeling, that you have a label on the drug that says accelerated approval. Do you think that would clear things up or would that just confuse issues?

MARKEY: Well, I think that if each patient and physician understood that the approval for the drug was only conditional, not permanent, that that would put real pressure on the FDA and the drug company to complete all of the tests as quickly as possible.

And, secondly, I also propose that there be fines which are possible to be imposed by the FDA on the drug company. In other words, right now the drug company keeps it on the market because the FDA doesn't have the nerve to take it off the market because it could be life-saving. But there is no penalty if the drug company drags its feet in conducting these tests. PILGRIM: Well, we certainly applaud your efforts, and thanks very much for explaining them to us, tonight, Congressman Ed Markey. Thank you.